Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER NINE
SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS INTENDED FOR USE IN ANIMALS
Section 56
Medicated feeding stuffs
(1) By way of derogation from Section 47 sub-section 1, medicated feeding stuffs may only be supplied by the manufacturer directly to the animal keeper, and only upon prescription issued by a veterinarian; this shall also apply in cases where the medicated feeding stuffs are manufactured in another Member State of the European Union or another State Party to the Agreement on the European Economic Area using medicated pre-mixes authorised for marketing within the purview of this Act or such medicated pre-mixes as possess the same qualitative and a comparable quantitative composition as medicated pre-mixes authorised for marketing within the purview of this Act, where the other medicinal product provisions valid within the purview of this Act are observed and the medicated feeding stuffs carry an accompanying certificate based on the sample certificate published by the Federal Ministry of Food and Agriculture. In the case of sentence 1 second half-sentence, the prescribing veterinarian shall immediately transmit a copy of the prescription to the authority responsible pursuant to Section 64 sub-section 1 for supervising compliance by the animal keeper with the regulations on medicinal products. Repeated dispensing on one prescription shall not be admissible. The Federal Ministry of Food and Agriculture is hereby empowered to issue ordinances containing regulations governing the form and content of the prescriptions, in consultation with the Federal Ministry and the Federal Ministry for Economic Affairs and Energy.
(2) For the manufacture of a medicated feeding stuff, only medicated pre-mixes may be used which are authorised for marketing pursuant to Section 25 sub-section 2 or are exempted from the need for a marketing authorisation pursuant to Section 36 sub-section 1. On the basis of a prescription, by way of derogation from sentence 1, a medicated feeding stuff may be manufactured from a maximum of three medicated pre-mixes, each of which is authorised for administration to the animal species in question, if:
1. no authorised medicated pre-mix exists for the therapeutic indication in question,
2. in the individual case, the medicated feeding stuff does not comprise more than two medicated pre-mixes containing an antimicrobially effective substance or at most one medicated pre-mix with several such substances and
3. a homogeneous and stable distribution of the active constituents in the medicated feeding stuff is guaranteed.
(3) If medicated feeding stuffs are manufactured, the mixed feed used for this purpose shall have to comply with the provisions of the legislation on feeding stuffs before and after the mixing procedure and it may not contain any antibiotic or coccidiostatic agent as a feeding stuff additive.
(4) The manufacturer of medicated feeding stuffs shall ensure that the daily dose of the medicinal product is contained in the mixed feed in a quantity which covers at least half of the daily feed ration of the animals under treatment and, in the case of ruminants, at least half of the daily supplementary feed requirement with the exception of mineral feed. The manufacturer of the medicated feeding stuffs shall label the mixtures ready for feeding before dispensing in such a way that on the label the word ‘Fütterungsarzneimittel’ (medicated feeding stuff), and the information about the percentage of the feed requirement they are intended to cover, as defined in sentence 1 is clearly visible.
(5) The veterinarian may only prescribe medicated feeding stuffs:
1. if they are intended for the animals treated by him/her,
2. if they are intended for the animal species and therapeutic indications specified in the package leaflets of the medicated pre-mixes,
3. if their use according to the therapeutic indications and quantity is justified in the light of the latest standard of veterinary medicinal science in order to achieve the treatment objective, and
4. if the amount of the medicated feeding stuffs prescribed for food-producing animals, which:
a) subject to letter b, contain medicated pre-mixes available only on prescription, is intended for use within 31 days of dispensing, or
b) contain antimicrobially effective substances, is intended for use within seven days of dispensing,
save where the authorisation conditions of the medicated pre-mix provide for a longer period of use.
Section 56a sub-section 2 shall apply mutatis mutandis to the prescription of medicated feeding stuffs. If medicated feeding stuffs are prescribed pursuant to sentence 1 number 4, Section 56a sub-section 1 sentence 2 shall also apply mutatis mutandis.
Section 56a
Prescription, dispensing and use of medicinal products by veterinarians
(1) The veterinarian may only prescribe or dispense medicinal products, which are not released for trade outside of pharmacies, to the animal keeper, subject to special provisions pursuant to sub-section 3, if:
1. they are intended for animals treated by him/her,
2. they have been authorised for marketing or may be placed on the market on the basis of Section 21 sub-section 2 number 4 in conjunction with sub-section 1 or fall within the scope of an ordinance pursuant to Section 36 or 39 sub-section 3 sentence 1 number 2 or may be placed on the market pursuant to Section 38 sub-section 1,
3. according to the marketing authorisation, they are intended for administration to the animal species under treatment in that specific therapeutic indication,
4. their use, according to the therapeutic indication and quantity, is justified in the light of the latest standard of veterinary medicinal science in order to achieve the treatment objective in the specific case, and
5. in the case of administration to food-producing animals,
a) subject to letter b, the prescribed or dispensed quantity of prescription-only medicinal products, is intended for use within 31 days of dispensing, or
b) the quantity of medicinal products, prescribed or dispensed, containing antimicrobially effective substances and not exclusively intended for local use according to the marketing authorisation conditions, is intended for use within seven days of dispensing,
save where the marketing authorisation conditions provide for a longer period of use.
In a particular treatment case, the veterinarian may only re-dispense or re-prescribe prescription-only medicinal products for administration to food-producing animals if he/she has examined the treated animals or the treated livestock within a period of 31 days prior to the day which, according to his/her treatment instructions, the last administration of the dispensed or prescribed medicinal product is intended to take place. Sentence 1 numbers 2 to 4 shall apply mutatis mutandis to the administration by the veterinarian. By way of derogation from sentence 1, the veterinarian may neither prescribe nor dispense medicated pre-mixes to the animal keeper.
(1a) Sub-section 1 sentence 3 shall not apply in cases where a veterinarian uses medicinal products in an animal he/she is treating and the medicinal products have been manufactured by him/her exclusively for this purpose.
(2) If the medicinal care required by the animals would otherwise be seriously jeopardized, and if there are no grounds to fear direct or indirect risk to human or animal health, the veterinarian may, in the case of individual animals or animals from a particular stock, by way of derogation from sub-section 2 sentence 1 number 3, also in conjunction with sub-section 1 sentence 3, prescribe, administer or dispense the medicinal products designated below which are authorised or exempted from authorisation:
1. a medicinal product which is authorised for the particular animal species and another therapeutic indication, if an authorised medicinal product is not available for the treatment of the particular animal species and the specific therapeutic indication;
2. a medicinal product which is authorised for a different species, if a suitable medicinal product pursuant to number 1 is not available for the species in question;
3. an authorised medicinal product for administration to human beings or, also by way of derogation from sub-section 1 sentence 1 number 2, also in conjunction with sub-section 1 sentence 3, a medicinal product which is authorised for use on animals in a Member State of the European Union or another State Party to the Agreement on the European Economic Area, if a suitable medicinal product, pursuant to number 2, is not available, in the case of food-producing animals, however, only such medicinal products from other Member States of the European Union or other State Party to the Agreement on the European Economic Area as are authorised for use in food-producing animals;
4. a medicinal product manufactured in a pharmacy or by the veterinarian pursuant to Section 13 sub-section 2 sentence 1 number 3 letter d, if a suitable medicinal product pursuant to number 3 is not available.
In the case of food-producing animals, however, the medicinal product may only be used by the veterinarian or administered under his/her supervision and may only contain pharmacologically active substances listed in Table 1 of the Annex to Regulation (EU) No. 37/2010. The veterinarian shall specify the length of the withdrawal period; all further details are regulated in the Veterinary In-House Dispensary Ordinance. Sentences 1 to 3 shall apply mutatis mutandis to medicinal products which are manufactured according to Section 21 sub-section 2 number 4 in conjunction with sub-section 2a. Registered homeopathic medicinal products or such homeopathic medicinal products as are exempted from registration, may be prescribed, dispensed and administered by way of derogation from sub-section 1 sentence 1 number 3; this shall apply to medicinal products which are intended for administration to food-producing animals if they contain only active substances listed in the Annex to Regulation (EU) No. 37/2010 as substances which do not require the stipulation of maximum levels.
(2a) By way of derogation from sub-section 2 sentence 2, medicinal products for equidae intended for food production, unless otherwise specified in Annex IX, Part II of the equidae passport within the meaning of Commission Regulation (EC) No. 504/2008 of 6 June 2008 implementing Council Directive 90/426/EEC as regards methods for the identification of equidae (OJ L 149 of 7.6.2008, p. 3) in the latest applicable version, can also be prescribed, dispensed or used if they contain substances that are listed in Regulation (EC) No. 1950/2006 of the Commission of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae (OJ L 367 of 22.12.2006, p. 33).
(3) The Federal Ministry of Food and Agriculture shall be empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat:
1. to stipulate requirements for the dispensing and prescribing of medicinal products for administration to animals also with a view to treatment,
2. to prohibit, subject to an ordinance pursuant to number 5, any deviation from the information to be contained in the instructions for use pursuant to Section 11 sub-section 4 sentence 1 numbers 3 and 5 in prescribing, dispensing or administering certain medicinal products containing antimicrobial substances intended for administration to animals, in so far as this is necessary to prevent a direct or indirect danger to human or animal health through the use of said medicinal products,
3. to prescribe that the veterinarian, in the context of the treatment of specific animals, in specific cases, must determine the sensitivity to specific antimicrobial substances of the pathogen causing a disease or have it determined,
4. to stipulate that:
a) veterinarians must keep records on the dispensing, prescription and administration, also with a view to treatment, of medicinal products not released for trade outside of pharmacies,
b) specific medicinal products may be used only by the veterinarian himself if such medicinal products:
aa) are capable of posing a danger to human and animal health, directly or indirectly, even when used in keeping with the intended purpose, if they are used in an unprofessional manner,
bb) are repeatedly used in considerable quantities in a manner which is not in keeping with the intended purpose and can therefore constitute a direct or indirect danger to human or animal health,
5. to prescribe that the veterinarian, in derogation of sub-section 2, in the case of specific medicinal products that contain anti-microbial substances, may
a) dispense or prescribe these only for the animal species or therapeutic indications envisaged in the marketing authorisation, or
b) administer specific medicinal products that contain anti-microbial substances only to the animal species or for the therapeutic indications envisaged in the marketing authorisation
in so far as this is necessary to maintain the efficacy of anti-microbial substances for the treatment of human beings and animals.
The ordinances pursuant to sentence 1 may, additionally:
1. stipulate, in the case of sentence 1 number 3, requirements regarding sampling, the samples to be taken, the testing procedure as well as the keeping of records,
2. in the case of sentence 1 number 4 letter a:
a) regulate the type, form and content of these records as well as the period for which they must be kept,
b) stipulate that records are to be summarised by the veterinarian at the request of the competent authority according to the latter’s specifications and placed at its disposal in so far as this is necessary to guarantee adequate supervision of the use of medicinal products in food-producing animals.
In ordinances pursuant to sentence 1 numbers 2, 3 and 5, care must be taken to ensure that the animals receive the necessary medicinal treatment at all times. The obligation to keep records may be restricted to certain medicinal products, therapeutic indications or forms of administration.
(4) The veterinarian shall not prescribe or dispense to animal keepers medicinal products determined by ordinance pursuant to sub-section 3 sentence 1 number 4 letter b.
(5) The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry by ordinance subject to the approval of the Bundesrat to set up a Commission on Veterinary Medicinal Product Use. The Commission on Veterinary Medicinal Product Use shall describe, in guidelines, the standard of veterinary medicinal science, particularly for the use of medicinal products containing antimicrobially effective substances. Further details on the composition and appointment of members and the procedure of the Commission on Veterinary Medicinal Product Use shall be determined in the ordinance. Further duties may also be transferred to the Commission on Veterinary Medicinal Product Use by ordinance.
(6) It shall be assumed that justification, according to the latest standards of veterinary medicinal science within the meaning of sub-section 1 sentence 1 number 4 or Section 56 sub-section 5 sentence 1 number 3 is given, as long as the guidelines of the Commission on Veterinary Medicinal Product Use pursuant to sub-section 5 sentence 2 have been observed.
Section 56b
Exceptions
The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat, to allow exceptions to Section 56a in so far as the necessary provision of medicinal care for the animals is otherwise seriously jeopardised.
Section 57
Acquisition and possession by keepers of animals, records
(1) The animal keeper may only acquire medicinal products that are not released for trade outside of pharmacies, for administration to animals, either in pharmacies or from the veterinarian treating the animals or, in those cases defined in Section 56 sub-section 1, from manufacturers. Other persons not defined in Section 47 sub-section 1 may acquire such medicinal products in pharmacies only. Sentence 1 shall not apply to medicinal products within the meaning of Section 43 sub-section 4 sentence 3. Sentences 1 and 2 shall not apply in so far as medicinal products that are authorised exclusively for administration to non-food producing animals are purchased,
1. by the animal keeper, through sale at a distance, pursuant to Section 43 sub-section 5 sentence 3 or 4, or
2. by other persons, not specified in Section 47 sub-section 1, through sale at a distance, pursuant to Section 43 sub-section 5 sentence 3,
or pursuant to Section 73 sub-section 1 number 1a. By way of derogation from sentence 1, the animal keeper may not purchase medicated pre-mixes.
(1a) Animal keepers may not have in their possession any medicinal products which are reserved by ordinance for administration exclusively by the veterinarian himself. This shall not apply if the medicinal product is intended for a purpose other than the administration to animals or if possession is allowed pursuant to Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock-farming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, p. 3).
(2) The Federal Ministry of Food and Agriculture is hereby empowered to stipulate, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat, that:
1. enterprises or persons who keep food-producing animals and place these animals or products manufactured from them on the market, and
2. other persons who are not specified in Section 47 sub-section 1
shall be required to keep records on the acquisition, the storage and the whereabouts of the medicinal products as well as a register or records of the administration of the medicinal products in so far as this is deemed necessary in order to guarantee the proper utilization of medicinal products and in so far as enterprises or persons pursuant to number 1 are concerned, this is necessary for the implementation of legal acts of the European Community or the European Union in this field. The ordinance may contain provisions regulating the type, form and content of these registers and records as well as the period for which they must be kept. The ordinance may also stipulate that, at the request of the competent authority and according to its specifications, the records are to be summarised by the animal keeper and placed at the former’s disposal in so far as this is necessary to ensure adequate supervision of the use of medicinal products in food-producing animals.
(3) The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat to stipulate that enterprises or persons who:
1. keep animals in an animal shelter or a similar facility or
2. commercially breed or keep vertebrate animals, except for food-producing animals, or take care of such animals on a temporary basis for other enterprises
shall keep records on the purchase of prescription-only medicinal products that have been purchased to treat the animals specified in numbers 1 and 2. The ordinance may also contain provisions regulating the type, form and content of these records as well as the period for which they must be kept.
Section 57a
Use by animal keepers
Animal keepers and other persons who are not veterinarians may only administer prescription-only medicinal products to animals if such medicinal products are prescribed or dispensed by the veterinarian who is treating the animals.
Section 58
Use in food-producing animals
(1) In addition to the requirements contained in Section 57a, animal keepers and other persons who are not veterinarians may administer prescription-only medicinal products or other medicinal products prescribed by or purchased from a veterinarian to food-producing animals subject to a measure by the competent authority pursuant to Section 58d sub-section 3 sentence 2 number 2, only according to treatment instructions from a veterinarian for the specific case. Medicinal products not subject to a prescription that are not released for trade outside of pharmacies and are not administered on the basis of treatment instructions from a veterinarian, may only be administered:
1. if they are authorised for marketing or fall within the scope of an ordinance pursuant to Section 36 or Section 39 sub-section 3 sentence 1 number 2, or are placed on the market pursuant to Section 38 sub-section 1,
2. to the animal species and in the therapeutic indications specified in the labelling or package leaflet and
3. in a quantity corresponding to the labelling of the medicinal product as to dosage and duration of administration.
By way of derogation from sentence 2, medicinal products within the meaning of Section 43 sub-section 4 sentence 3 may only be used in accordance with the instruction of the veterinary authorities under Section 43 sub-section 4 sentence 4.
(2) The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry, to prohibit by ordinance subject to the approval of the Bundesrat, medicinal products intended for administration to food-producing animals from being placed on the market for particular therapeutic indications or areas of application or from being used for these purposes, as long as this is deemed necessary in order to prevent an indirect hazard to human health.
(3) The Federal Ministry of Food and Agriculture is, furthermore, empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat, to specify details with regard to technical facilities for the oral administration of medicinal products to animals, the maintenance and cleaning of these facilities as well as regarding the animal keeper’s duty to take due care so as to reduce any contamination of anti-microbial substances.
Section 58a
Notifications about animal keeping
(1) In accordance with sub-section 2, any person who professionally or commercially keeps cattle (Bos taurus), pigs (Sus scrofa domestica), chickens (Gallus gallus) or turkeys (Meleagris gallopavo) is to notify the competent authority of the keeping of these animals no later than 14 days after commencement of keeping the animals, stating the particular species and the enterprise at which the animals are kept (livestock enterprise). In addition, the notification is to contain the following information:
1. name of the animal keeper,
2. address of the livestock enterprise and the registration number issued to the livestock enterprise in accordance with animal health provisions on the handling of livestock,
3. supplemented,
a) where cattle are kept, by a declaration of whether the animals in question are fattening calves aged up to eight months or fattening cattle aged eight months and above,
b) where pigs are kept, by a declaration of whether the animals in question are piglets up to and including 30 kg or fattening pigs over 30 kg
(type of production).
(2) The obligation to notify, pursuant to sub-section 1 sentence 1, shall apply
1. to chickens and turkeys intended for meat production (fattening) and from the date on which the animals in question hatch, and
2. to cattle and pigs intended for fattening and from the date on which the animals in question are weaned from the dam.
(3) Any person who on 1 April 2014 has animals in his/her keeping, within the meaning of sub-section 1 sentence 1, is to provide the notification pursuant to sub-section 1 sentences 1 and 2 by 1 July 2014 at the latest.
(4) Any person subject, pursuant to sub-section 1 or 3, to an obligation to notify shall make notification of any changes to the notifiable information within 14 working days. The notification pursuant to sub-section 1 or 3, each in conjunction with sentence 1, is to be provided in electronic or written form. The prescribed notifications may be performed by a third party as long as the animal keeper has advised the competent authority to this effect, stating the name of the third party. Sub-sections 1 and 3 and sentence 1 shall not apply in so far as the required information has already been provided pursuant to animal health provisions on the handling of livestock. In these cases, the authority competent for the implementation of animal health provisions on the handling of livestock shall transmit the required information to the authority competent for the implementation of sub-sections 1 and 3 and sentence 1. In accordance with Section 10 of the Data Protection Act, the transmission pursuant to sentence 5 may be effected via an automated data retrieval procedure.
Section 58b
Notifications about the use of medicinal products
(1) Any person who keeps animals, the keeping of which is subject to mandatory notification requirements pursuant to Section 58a shall notify the competent authority, on a half-yearly basis, in respect of any medicinal products containing antibacterially active substances which have been used on the animals being kept, of each treatment, taking into account the type of production, at each livestock enterprise that has been issued with a registration number in accordance with the animal health provisions on the handling of livestock. Such notification shall contain the following information:
1. the name of the medicinal product used,
2. the number and species of the animals treated,
3. subject to sub-section 3, the number of days of treatment,
4. the total amount of medicinal products containing antibacterially active substances that was used,
5. for each half-yearly period, the number of animals of each species that were:
a) being kept at the enterprise at the beginning of the half-yearly period in question,
b) introduced into the enterprise over the course of each half-yearly period,
c) removed from the enterprise over the course of each half-yearly period.
Notifications provided pursuant to sentence 1 number 5 letters b and c are to include the date of each treatment. The notification is to be submitted no later than the fourteenth day of the month that follows the last month of the half-yearly period in which the treatment was carried out. Section 58a sub-section 4 sentences 2 and 3 shall apply mutatis mutandis.
(2) By way of derogation from sub-section 1 sentence 1, the information listed in sub-section 1 sentence 1 numbers 1 to 4 may be replaced by the following information:
1. the name of the medicinal product purchased from or prescribed by the veterinarian for the treatment,
2. the number and species of the animals for which treatment instructions were issued by the veterinarian,
3. the identity of the animals for which treatment instructions were issued by the veterinarian, in so far as this information indicates the type of use,
4. subject to sub-section 3, the duration of the prescribed treatment in days,
5. the total amount of the medicinal product used or dispensed by the veterinarian.
Sentence 1 shall only apply if the animal keeper:
1. at the time the medicinal product was purchased or prescribed, provided the veterinarian with written assurance that he/she will not deviate from the treatment instructions without consulting the veterinarian, and
2. when submitting the notification, as required by sub-section 1 sentence 1, to the competent authority, provided written assurance that the treatment did not deviate from the veterinarian’s treatment instructions.
Section 58a sub-section 4 sentences 2 and 3 shall apply mutatis mutandis with regard to sentence 1.
(3) With medicinal products that contain antibacterially active substances and that exhibit therapeutic drug levels for longer than 24 hours, the veterinarian shall notify the animal keeper of the number of treatment days within the meaning of sub-section 1 sentence 1 number 3, supplemented by the number of days for which the particular medicinal product retains its therapeutic drug level. In addition to sub-section 1 sentence 1 number 3, the animal keeper shall also provide notification of these days as treatment days.
Section 58c
Determining the treatment frequency
(1) For each enterprise that has been issued with a registration number in accordance with the animal health provisions on the handling of livestock and the corresponding species of the animals being kept, taking into account the type of production, the competent authority shall ascertain, for each half-yearly period, the average number of treatments involving antibacterially active substances on the basis of the procedure for calculating treatment frequency of 21 February 2013 (Federal Gazette AT 22.02.2013 B2), namely by:
1. multiplying the number of treated animals with the number of treatment days for each substance used and then adding together the resulting figures for all of the substances administered during the half-yearly period, and subsequently
2. dividing the figure resulting from number 1 by the average number of animals of the affected species that were kept during the half-yearly period
(half-yearly treatment frequency in enterprises).
(2) By no later than the end of the second month of the half-yearly period that follows the notifications from the previous half-yearly period pursuant to Section 58b sub-section 1 sentence 1, the competent authority shall notify the Federal Office of Consumer Protection and Food Safety, for the purposes of sub-section 4 and Section 77 sub-section 3 sentence 2, in anonymised form of the respective half-yearly treatment frequency ascertained pursuant to sub-section 1. In addition, the competent authority shall provide the Federal Institute for Risk Assessment, at the latter’s request in each case, with the half-yearly therapy frequencies ascertained pursuant to sub-section 1, in anonymised form, together with the information listed in Section 58b sub-section 1 sentence 1 number 4, in so far as this is necessary for the Federal Institute for Risk Assessment to conduct a risk assessment in the area of resistance to antibiotics. In accordance with Section 10 of the Federal Data Protection Act, the notifications as required by sentences 1 and 2 may be made via an automated data retrieval procedure.
(3) If the Laender establish a joint agency for the purposes of sub-section 1, the information listed in Sections 58a and 58b is to be transmitted to this agency. The agency shall then ascertain the half-yearly treatment frequency in enterprises in accordance with the procedure for calculating treatment frequency described in sub-section 1 and shall transmit this information to the authorities specified in sub-section 2 sentences 1 and 2. Sub-section 2 sentence 3 shall apply mutatis mutandis.
(4) From the data it receives on half-yearly treatment frequency in enterprises, the Federal Office for Consumer Protection and Food Safety shall ascertain:
1. as the first parameter, the median (the value below which 50 per cent of all recorded half-yearly therapy frequencies fall), and
2. as the second parameter, the third quartile (the value below which 75 per cent of all recorded half-yearly therapy frequencies fall)
of the nationwide half-yearly treatment frequency for each animal species referred to in Section 58a sub-section 1. The Federal Office of Consumer Protection and Food Safety shall promulgate these parameters in the Federal Gazette by the end of the third month of the half-yearly period following the notifications from the previous half-yearly period pursuant to Section 58b sub-section 1, breaking them down according to type of production.
(5) The competent authority or the joint agency pursuant to sub-section 3 shall notify the animal keeper of the half-yearly treatment frequency ascertained pursuant to sub-section 1 for each species of animal in his/her keeping within the meaning of Section 58a sub-section 1, taking into account the type of production. The animal keeper may also request information about the data which have been collected, saved or otherwise processed in accordance with Sections 58a and 58b, in so far as these data relate to his/her enterprise.
(6) The data collected pursuant to Sections 58a and 58b, or transmitted to, pursuant to sub-section 5 and saved by the competent authority or the joint agency pursuant to sub-section 3, are to be preserved for a period of six years. This period shall begin on the day following 30 June or 31 December of the half-yearly period in which the nationwide half-yearly treatment frequency was promulgated pursuant to sub-section 4. Upon the expiry of this period, the data are to be deleted.
Section 58d
Reduction in treatment with antibacterially active substances
(1) In order to contribute towards effectively reducing the use of medicinal products containing antibacterially active substances, any person who keeps animals professionally or commercially within the meaning of Section 58a sub-section 1 sentence 1 is:
1. to ascertain, two months after the data on the nationwide half-yearly treatment frequency are promulgated pursuant to Section 58c sub-section 4 sentence 2, whether, in the expired period, his/her enterprise’s half-yearly treatment frequency for the individual species of animals kept, taking into account the type of production, and in respect of the livestock enterprise for which a registration number has been issued to him/her in accordance with the animal health provisions on the handling of livestock, is above parameter 1 or parameter 2 of the nationwide half-yearly treatment frequency;
2. to record the ascertainment pursuant to number 1 in his/her company documentation without delay once it has been made.
(2) If an animal keeper’s half-yearly treatment frequency, in respect of the livestock enterprise for which a registration number was issued to him/her in accordance with the animal health provisions on the handling of livestock:
1. is above parameter 1 of the nationwide half-yearly treatment frequency, the animal keeper is to examine, by consulting a veterinarian, what reasons may have led to this parameter being exceeded, and how the treatment of animals kept by him /her within the meaning of Section 58a sub-section 1 with medicinal products containing antibacterially active substances may be reduced; or
2. is above parameter 2 of the nationwide half-yearly treatment frequency, the animal keeper is to draw up a written plan, based on veterinary advice, within two months of the date established pursuant to sub-section 1 number 1, containing measures that aim to reduce treatment with medicinal products containing antibacterially active substances.
If the examination by the animal keeper pursuant to sentence 1 number 1 indicates that the treatment with the medicinal products in question can be reduced, the animal keeper is to take steps which can lead to a reduction. The animal keeper is to ensure that the animals receive the necessary medicinal treatment while the measure pursuant to sentence 1 number 1 and the steps listed in the plan pursuant to sentence 1 number 2 are carried out. The plan pursuant to sentence 1 number 2 is to be supplemented to include a time schedule if the measures to be taken pursuant to the plan cannot be fulfilled within six months.
(3) The plan pursuant to sub-section 2 sentence 1 number 2 is to be submitted, unsolicited, to the competent authority, at the latest two months after the date established pursuant to sub-section 1 number 1. In so far as is necessary for the effective reduction of treatment with medicinal products containing antibacterially active substances, the competent authority may, in respect of the animal keeper
1. issue an order that the plan be amended or supplemented,
2. issue orders, taking into account the state of veterinary science, to reduce treatment with medicinal products containing antibacterially active substances, in particular with regard to:
a) compliance with generally recognised guidelines on the use of medicinal products containing antibacterially active substances, or parts thereof, and
b) vaccination of the animals,
3. with regard to preventing diseases, and taking into account the state of good practice in agriculture or good hygienic practice in animal husbandry, issue orders regarding the keeping of the animals, in particular with regard to the feeding, the hygiene, the type and manner of the fattening, including the length of the fattening period, the equipping of the stalls, the fittings of the stalls and the stocking density,
4. issue an order that medicinal products containing antibacterially active substances may, for a specified period, be used in a livestock enterprise only by the veterinarian, if the half-yearly treatment frequency ascertained for the animal species held by an animal keeper, taking into account the type of production, is considerably higher than parameter 2 of the nationwide treatment frequency twice in a row.
The order issued pursuant to sentence 2 Number 1 must give the aim pursued by the amendment of or addition to the plan. Orders issued pursuant to sentence 2 numbers 2, 3 and 4 must ensure that the animals receive the necessary medicinal treatment at all times. The competent authority may instruct the animal keeper to take measures pursuant to sentence 2 number 3 even if these measures revoke or limit rights granted to the animal keeper by other administrative acts or legislation, in so far as the necessary reduction of treatment with medicinal products containing antibacterially active substances cannot be achieved by means of other effective measures and the competent authority has actual findings on the effectiveness of the further measures. Sentence 5 shall not apply in so far as directly applicable legal provisions of the European Community or of the European Union exist to the contrary.
(4) If the animal keeper has not complied with orders issued pursuant to sub-section 3 sentence 2 numbers 1 to 4 (in the case of number 3 also in conjunction with sentence 5), and if the half-yearly treatment frequency ascertained for the respective animal species kept by an animal keeper, taking into account the type of production, is for this reason repeatedly above parameter 2 of the nationwide treatment frequency, the competent authority may order the suspension of animal husbandry in the animal keeper’s enterprise for a specified period, up to a maximum of three years. The order to suspend the animal husbandry is to be revoked as soon as it is ensured that the orders described in sentence 1 are being complied with.
Section 58e
Authority to issue ordinances
(1) The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat, to regulate the details regarding the type, form and content of the notifications submitted by the animal keeper pursuant to Section 58a sub-section 1 or Section 58b. The ordinance pursuant to sentence 1 may provide that
1. the notifications pursuant to Section 58b sub-section 1 or sub-section 3 may be replaced by data or records which are to be transmitted by reason of other medicinal drug regulations, in particular under an ordinance pursuant to Section 57 sub-section 2,
2. enterprises up to a certain stock size shall be exempted from the requirements of Sections 58a and 58b.
An ordinance pursuant to sentence 2 number 2 may only be issued in so far as:
1. the exemption of the enterprises will not jeopardise the achievement of the aim of reducing treatment with medicinal products containing antibacterially active substances, and
2. the calculation of the parameters of the nationwide half-yearly treatment frequency remains representative.
(2) The Federal Ministry of Food and Agriculture shall be empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat:
1. for the purpose of calculating the median and the quartiles of the nationwide half-yearly treatment frequency, to lay down requirements and details regarding the calculation of the parameters,
2. to regulate the details, including the procedure for:
a) the provision of information pursuant to Section 58c sub-section 5,
b) the deleting of data pursuant to Section 58c sub-section 6.
(3) The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat, to regulate the details of:
1. the records pursuant to Section 58d sub-section 1 number 2,
2. the content and scope of the plan referred to in Section 58d sub-section 2 sentence 1 number 2 to reduce the treatment with medicinal products containing antibacterially active substances, and
3. the requirement concerning the transmission, including the procedure pursuant to Section 58d sub-section 3 sentence 1.
(4) The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry, by ordinance subject to the approval of the Bundesrat, to include food-producing fish within the scope of Sections 58a to 58f and of the ordinances issued to implement these regulations, in so far as this is necessary to achieve the aim of reducing treatment with medicinal products containing antibacterially active substances. An ordinance pursuant to sentence 1 may be issued only when the results of an official, or officially commissioned, nationwide research project on treatment with medicinal products containing antibacterially active substances for food-producing fish have been published in the Federal Gazette.
Section 58f
Use of data
The data pursuant to Sections 58a to 58d may only be processed and used for the purpose of determining and calculating treatment frequency, supervising compliance with Sections 58a to 58d and prosecuting and punishing violations of regulations on medicinal products. By way of derogation from sentence 1, the competent authority may, in so far as:
1. it has grounds for suspecting that there has been a violation of regulations on food and feed, animal welfare or animal health, may transmit the data pursuant to Sections 58a to 58d to the authorities competent for prosecuting violations, in so far as these data are necessary to prosecute the violation,
2. the data pursuant to Sections 58a to 58d are necessary for the evaluation pursuant to Section 58g, transmit these data in anonymised form as prescribed in sentence 3, through the competent highest Land authority, to the Federal Ministry of Food and Agriculture.
The Federal Ministry of Food and Agriculture shall publish, in the Federal Gazette, the type of data to be transmitted for the purpose of evaluation and the date of their transmission. The Federal Ministry of Food and Agriculture and the competent highest Land authority may process and use the data transmitted to them pursuant to sentence 2 number 2 solely for the purpose of evaluation pursuant to Section 58g. The data transmitted pursuant to sentence 2 number 2 shall be deleted at the end of the legislative period of the German Bundestag in which the report pursuant to Section 58g was transmitted to the Bundestag, in so far as the data were not included in the report.
Section 58g
Evaluation
The Federal Ministry of Food and Agriculture shall report to the German Bundestag, five years after the entry into force of this Act, on the effectiveness of the measures taken pursuant to Sections 58a to 58d.
Section 59
Clinical trial and residue testing in food-producing animals
(1) A medicinal product within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 may be administered by the manufacturer or on his/her behalf, by way of derogation from Section 56a sub-section 1, for the purposes of clinical trials and residue tests, if the application is limited to a test which, in accordance with the currently prevailing level of scientific knowledge, is necessary in both type and extent.
(2) The animals on which these tests are conducted may not be used for food production. Sentence 1 shall not apply if the competent higher federal authority has stipulated an appropriate withdrawal period. The withdrawal period must:
1. at least correspond to the withdrawal period pursuant to the Ordinance on Veterinary In-House Dispensaries and, where applicable, include a safety factor which takes into account the type of medicinal product, or
2. if maximum residue levels that have been set in the Annex to Regulation (EU) No. 37/2010 ensure that these maximum levels are not exceeded in foods derived from these animals.
The manufacturer shall submit to the competent higher federal authority the test results concerning residues of the medicinal products used and their conversion products in foods, stating the detection method used.
(3) Where a clinical trial or residue test is conducted on food-producing animals, the notification required under Section 67 sub-section 1 sentence 1 must contain, in addition, the following information:
1. name and address of the manufacturer and of the persons conducting the tests on his/her behalf,
2. the type and purpose of the test,
3. the species and number of animals envisaged for the tests,
4. the location, date of commencement and envisaged duration of the tests, and
5. information about the envisaged use of the animal products which are obtained either during or upon completion of the tests.
(4) Records shall be kept on the tests carried out and shall be presented to the competent authority upon request.
Section 59a
Trade in substances and preparations from substances
(1) Persons, enterprises and establishments specified in Section 47 sub-section 1 shall not acquire substances or preparations from substances, the use of which in the manufacture of medicinal products for animals is prohibited by ordinance pursuant to Section 6, for the purpose of manufacturing such medicinal products or of administration to animals, nor shall they offer for sale, store, package, carry with them or place them on the market for the purpose of such a manufacturing activity or administration. Animal keepers as well as other persons, enterprises and establishments not specified in Section 47 sub-section 1 shall not acquire, store, package or carry with them such substances or preparations, unless they are intended for a manufacturing activity or use not prohibited by ordinance pursuant to Section 6.
(2) Veterinarians may only obtain substances or preparations from substances that are not released for trade outside of pharmacies for administration to animals, and such substances and preparations may only be distributed to veterinarians, if they have been authorised for marketing as medicinal products or if they may be traded without a marketing authorisation on the basis of Section 21 sub-section 2 number 3 or 5 or on the basis of an ordinance pursuant to Section 36. Animal keepers may only acquire or store them for administration to animals if they have been prescribed as medicinal products or dispensed by a veterinarian. Other persons, enterprises and establishments not specified in Section 47 sub-section 1, shall not acquire, store, package, carry with them or place on the market substances or preparations from substances determined by an ordinance pursuant to Section 48, unless the substances or preparations are intended for a purpose other than the administration to animals.
(3) The foregoing shall be without prejudice to the provisions of the Feeding stuffs Act.
Section 59b
Substances for conducting residue tests
The pharmaceutical entrepreneur shall place at the disposal of the competent authority, upon request, in exchange for an appropriate compensation, sufficient quantities of the substances needed to conduct the residue tests in the case of medicinal products intended for food-producing animals. In the case of medicinal products which are no longer being placed on the market by the pharmaceutical entrepreneur, the provisions contained in sentence 1 shall be valid for a period of three years starting from the last date on which the pharmaceutical entrepreneur places the medicinal product on the market, but ending at the latest on the expiry date, indicated pursuant to Section 10 sub-section 7, of the last batch placed on the market.
Section 59c
Obligations to keep records of substances that can be used as veterinary medicinal products
Enterprises and establishments that manufacture, store, import or market substances or preparations from substances which can be used as veterinary medicinal products or in the manufacture of veterinary medicinal products and which display anabolic, infection-inhibiting, parasite-repelling, anti-inflammatory, hormonal or psychotropic characteristics, shall keep records on the acquisition or sale of these substances or preparations from substances which indicate the name of the previous supplier or the recipient as well as the amounts received or delivered in each case, shall preserve these records for at least three years and shall submit them, upon request, to the competent authority. Sentence 1 shall also apply to persons who carry out these activities on a professional basis. In the case of substances or preparations from substances with a thyrostatic, oestrogenic, androgenic or gestagenic effect or ß-agonists with an anabolic effect, these records shall take the form of a register in which the amounts manufactured or purchased, as well as the amounts supplied for the purpose of or used in the manufacture of medicinal products, are documented in chronological order along with the name of the previous supplier and the recipient.
Section 59d
Administration of pharmacologically active substances to food-producing animals
Pharmacologically active substances that:
1. are listed as prohibited substances in Table 2 of the Annex to Commission Regulation (EU) No. 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15 of 20.1.2010, p. 1), last amended by Commission Implementing Regulation (EU) No. 2019/238 (OJ L 39 of 11.2.2019, p. 4), or
2. are not listed in the Annex to Regulation (EU) No. 37/2010,
may not be administered to a food-producing animal. Sentence 1 shall not apply in the cases governed by Section 56a sub-section 2a and Article 16 paragraph 2 of Regulation (EC) No. 470/2009, nor to the administration of feeding stuffs which contain authorised feed additives.
Section 60
Pet animals
(1) The provisions in Section 21 to 39d and Section 50 shall not apply to medicinal products intended exclusively for administration to aquarium fish, cage or singing birds, carrier-pigeons, terrarium animals, small rodents, ferrets or rabbits not used for food production and which are authorised for marketing outside of pharmacies.
(2) The provisions on the manufacture of medicinal products shall apply on condition that the evidence pertaining to two years’ practical experience according to Section 15 sub-section 1 is not required.
(3) The Federal Ministry of Food and Agriculture is hereby empowered to extend, in agreement with the Federal Ministry for Economic Affairs and Energy and the Federal Ministry, by ordinance subject to the approval of the Bundesrat, the regulations governing marketing authorisations to medicinal products used for the animals specified in sub-section 1, in so far as it is deemed advisable in order to prevent either a direct or indirect hazard to human or animal health.
(4) The competent authority may authorise exceptions to Section 43 sub-section 5 sentence 1, where the supply of medicinal products for the animals specified in sub-section 1 is concerned.
Section 61
Powers of veterinary schools
Facilities belonging to veterinary schools at university level, which are directed by a veterinarian or pharmacist and are involved in dispensing medicinal products for animals under treatment there, shall have the same rights and obligations as a veterinarian under the regulations of this Act.
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